The Biostatistics Core for this program project is staffed with members of the Biostatistics and Informatics Shared Resource of the Masonic Cancer Center. The working principles of this Core reflect those delineated in a recent report from the working group convened by the Royal Statistical Society to study statistical and scientific issues related to 'First in man Studies'(March 2007). Their views are exemplified by the quote "Statistician's input concerns matters of ethics, science, and public health, reporting standards, practicality and common sense, not just the purely methodological." In addition, the team that prepared this application will also support the critical need for sound, secure and efficient data systems and appropriate quality assurance and quality control procedures. To that end, the primary objective of the Biostatistics Core is to contribute to the science and operation of the program project by participating fully in its activities as it has for the preparation of this application. This includes assistance and direction in experimental design, quality control, data collection and management, and statistical data analysis through consultation and collaboration. The Specific Aims of the Core are as follows: SA 1: Assist in experimental designs and provide data analysis plans. SA 2: Develop new biostatistical methods when necessary and appropriate SA 3: Implement Quality Assurance (QA) plans for all data collection activities SA 4: Support existing and develop new (when necessary) database applications for data collection and integration.